Vitamin D + Omega-3 for Depression

(VITAL-DEP Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Psychotropics, Mood disorder agents

Disqualifiers: Depression, Substance abuse, Bipolar, Schizophrenia, PTSD, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

18353 Participants Needed

Trial Summary

What is the purpose of this trial?

The VITamin D and OmegA-3 TriaL (VITAL; NCT 01169259) is an ongoing randomized clinical trial in 25,871 U.S. men and women investigating whether taking daily dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor® fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. This ancillary study is being conducted among participants in VITAL and will examine whether vitamin D or fish oil: 1) reduces risk of clinical depressive syndrome, 2) yields better mood scores over time, compared to placebo.

Research Team

Olivia I Okereke, MD, SM

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults in the VITAL study without a history of major neurological disorders, clinical hypothyroidism, significant depression, or recent substance abuse. They shouldn't be on psychotherapy or psychotropics (except mild sedatives) and must not have had core depressive symptoms for two weeks in the past two years.

Inclusion Criteria

I am not currently in psychotherapy or taking any mood-altering drugs, except for mild sleep aids.

I haven't had a major neurological disorder or delirium in the last year.

I haven't had major depression symptoms for 2+ weeks in the last 2 years.

Treatment Details

Interventions

• Fish Oil Placebo
• Omega-3 Fatty Acids (Fish Oil)
• Vitamin D3
• Vitamin D Placebo

Trial Overview The VITAL-DEP study tests if daily supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (1 gram fish oil) can prevent clinical depression and improve mood over time compared to placebos in individuals without prior cancer, heart disease, or stroke.

Participant Groups

Group I: Vitamin D + fish oil placebo Active Control 2 Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day Fish oil placebo

Group II: Vitamin D placebo + fish oil placebo Active Control 2 Interventions

Vitamin D placebo Fish oil placebo

Group III: Vitamin D + fish oil Active Control 2 Interventions

Vitamin D3 (cholecalciferol), 2000 IU per day Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

Group IV: Vitamin D placebo + fish oil Active Control 2 Interventions

Vitamin D placebo Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid \[EPA\] and 375 mg of docosahexaenoic acid \[DHA\])

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+